Metal working – Method of mechanical manufacture – Assembling or joining
Reexamination Certificate
2000-12-08
2004-01-27
Vidovich, Gregory (Department: 3726)
Metal working
Method of mechanical manufacture
Assembling or joining
C053S410000, C215S249000
Reexamination Certificate
active
06681475
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an improved method of sealing a medical container, such as a vial containing a medicament, drug or vaccine, which eliminates the problems associated with malleable metal caps or collars, such as aluminum. The method of this invention may be used to seal a vial having an elastomeric stopper with a polymeric closure or collar. The method of this invention may also be used for sealing a vial or other medical container with a fluid transfer set separate from or integral with the collar portion of the closure.
BACKGROUND OF THE INVENTION
It is conventional to store medicaments, drugs or vaccines in a sealed vial or other container for later use. Such medicaments, drugs or vaccines may be in a dry or powdered form to increase the shelf life of the drugs and reduce inventory space. Such dry or powdered medicaments, drugs or vaccines are generally stored in a sealed vial and reconstituted in liquid form for administration to a patient by adding a diluent or solvent. Alternatively, the medicament, drug or vaccine may be in liquid or even gaseous form. A conventional vial for storing medicaments generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper or septum which generally includes a tubular portion inserted into the neck of the vial and a planar radial rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. The aluminum cap includes a tubular portion which surrounds the rim portions of the stopper and vial, an inwardly projecting annular portion which overlies the rim portion of the stopper and a distal end portion which is crimped radially into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).
The radial portion of the aluminum cap which overlies the stopper rim portion may be closed, in which case the aluminum cap is removed by “peeling” the aluminum cap from the vial. A pre-slit tab located in the middle area may be provided which overlies the vial rim, permitting the cap to be torn from the top and peeled from the vial prior to use. This closed embodiment of an aluminum cap has several disadvantages. First, the tearing of the metal cap creates sharp edges which may cut or damage sterile gloves and cut the person administering the drug, thereby exposing both the healthcare worker and the patient to disease and contamination of the drug. Second, the tearing of the aluminum cap generates metal particles which may also contaminate the drug, medicament or vaccine. The dangers associated with the tearing of an aluminum cap has been solved in part by adding a “flip-off” plastic cap. In one such embodiment, the aluminum collar includes a central opening and a shallow plastic cup-shaped cap is received over the aluminum collar having a central projecting riveting portion which is received and secured in the central opening of the aluminum collar. The plastic cap is then removed by forcing the flip-off cap away from the aluminum collar, which tears an annular serrated portion surrounding the central opening and exposes an opening in the collar for receipt of a hypodermic needle or the like. This embodiment reduces but does not eliminate the possibility of tearing the sterile gloves of the healthcare worker. More importantly, however, aluminum dust is still created which may contaminate the medicament. It is also important to note that metallic dust is also created simply by forming and affixing the aluminum collar to the vial because aluminum dust is created in forming the aluminum collar, crimping of the collar and removal of the flip-off plastic cap.
Aluminum collars have also been used to secure a fluid transfer set on medicament vials. Transfer sets may be utilized, for example, to transfer fluid from a syringe to a vial, such as to reconstitute a dry or powdered drug in a vial by adding a diluent or solvent. The reconstituted drug may then be withdrawn from the vial by the syringe. The inner surface of the transfer set may be part of the drug fluid path and the aluminum collar or ring may bring aluminum particles in the sterile room where the drug is added to the vial or into the drug fluid path contaminating the drug. There have been attempts to reduce this problem by applying a coating, such as a polymeric coating, to the aluminum cap or collar. Finally, the prior art also includes snap-on cup-shaped plastic caps or collars having a radially inwardly projecting end portion which is snapped over the rim portion of the vial. Snap-on plastic collars, however, do not assure adequate sealing of the vial or fully accommodate the tolerances of standard vials and stoppers as required.
The need therefore remains for a method of sealing vials and other medical containers which may be utilized for sealing conventional medical containers, such as medicament vials or cartridges, which assures sealing of the container and which achieves a good level of cleanliness, without metal particles or dust which will contaminate the medicament, drug or vaccine, the transfer set or clean room and which does not expose the health care worker to sharp edges. The method of sealing a medical container of this invention eliminates these problems and permits sealing of medical containers in an aseptic environment.
SUMMARY OF THE INVENTION
As set forth above, the method of sealing a vial or other medical container with a plastic closure of this invention eliminates the problems associated with malleable metal or aluminum caps or collars, but which accommodates build-up of tolerances of the rim portion of the container and the elastomeric stopper, when used. The plastic or polymeric closure of this invention is relatively inexpensive to manufacture and use in the method of this invention. The method of this invention may be utilized to seal a conventional medical vial with a polymeric cap, a collar in combination with a flip-off cap or with a collar used to secure and seal a transfer set on a vial for transferring fluid between the vial and a second container, such as a hypodermic syringe. As used herein, the term “closure” is generic to either a cap or collar alone or in combination with a transfer set.
As stated above, the method of sealing a container with a plastic closure of this invention may be utilized with a conventional vial or other medical container having an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The method of sealing a medical container with a plastic closure of this invention includes forming a plastic closure from a polymer, preferably formed by injection molding, which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain a seal between the plastic closure and the container following radial deformation. The plastic closure formed by the method of this invention includes a generally cylindrical tubular portion having an internal diameter generally equal to or preferably slightly greater than an outside diameter of the rim portion of the container and an integral radial rim portion. In the preferred method of this invention, the plastic closure is formed by injection molding a polymer alloy comprising a relatively malleable soft polymer and a relatively rigid polymer. The closure may be formed by co-injecting a polymer alloy which preferably includes a polycarbonate as the relatively rigid polymer.
The method of this invention then includes telescopically disposing the tubular portion of the closure over the rim portion of the container with the radial rim portion of the closure overlying the rim port
Jansen Hubert
Niermann Volker
Thibault Jean-Claude
Becton Dickinson and Company
Fortunato David M.
Kenny Stephen
Vidovich Gregory
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